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Effects of Low Dose Ozone on Airway Inflammatory Responses in Adults With Asthma - Sedentary Nasal Ozone (Asthma SNOZ)

Primary Purpose

Asthma, Allergic

Status

Suspended

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Ozone

About this trial

This is an interventional basic science trial for Asthma, Allergic

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Ages 18-45, both sexes included
Mild intermittent asthma, defined as daytime asthma symptoms no more than 2 times per week, night time asthma symptoms no more than 2 times per month, FEV1 >80% of predicted, and asthma exacerbation requiring oral steroids 1 time or less per year.
Good general health as evidenced by medical history
Vital signs will be within normal limits on admission to the study: oxygen saturation by pulse oximetry (SpO2) > 94%, systolic blood pressure between 150-90 mm Hg, diastolic blood pressure between 100-60 mm Hg, afebrile.
FEV1 of at least 80% of predicted at baseline
Able to provide informed consent
Proof of Covid Vaccination

Exclusion Criteria:

Any chronic medical condition considered by the PI as a contraindication to the exposure study including significant cardiovascular disease, diabetes, chronic renal disease, chronic thyroid disease, history of chronic infections/immunodeficiency, history of tuberculosis
Physician directed emergency treatment for an asthma exacerbation within the preceding 12 months
Orthopedic injuries or impediments that would preclude bicycle or treadmill exercise
Viral upper respiratory tract infection within 4 weeks of challenge.
Any acute infection requiring antibiotics within 4 weeks of exposure or fever of unknown origin within 2 weeks of challenge.
Individuals who use daily controller medication for asthma. Pre-treatment with a short acting bronchodilator prior to exercise is allowed.
Nasal surgery within 6 months
Mental illness or history of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements.
Any recent or current use of nicotine
History of intubation for asthma
Pregnancy or nursing an infant as EPA strictly prohibits intentional exposure for research to this population.
Covid infection in the past 90 days

Sites / Locations

University of North Carolina CEMALB

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

6 hour Filtered Air (FA) followed by O3 exposure

6 hour O3 exposure followed by FA exposure

Arm Description

For the first exposure session, participants are exposed to filtered air (FA) for 6 hours. For the second exposure session, the same participant will be exposed to ozone at a concentration of 0.07ppm for 6 hours.

For the first exposure session, a participant will be exposed to ozone at a concentration of 0.07ppm for 6 hours. For the second exposure session, the same participant will be exposed to FA for 6 hours.

Outcomes

Primary Outcome Measures

Change in Percent (%) predicted forced expiratory volume at one second (FEV1)

Change from baseline %predicted FEV1 post-O3 versus post-air exposure.

Secondary Outcome Measures

Change in Percent (%) predicted forced vital capacity (FVC)

Change from baseline %predicted FVC post-O3 versus post-air exposure.

Change in Percent eosinophils in induced sputum

% eosinophils in induced sputum (24 hrs post ozone - post air)

Change in Percent (%) neutrophils in induced sputum

% neutrophils in induced sputum (24 hrs post ozone - post air)

Change in Eosinophils per mg of induced sputum

Eosinophils per mg of induced sputum (24 hrs post ozone - post air)

Change in neutrophils per mg of induced sputum

Neutrophils per mg of induced sputum (24 hrs post ozone - post air)

Change in Cytokine concentrations in induced sputum picograms per milliliter (pg/mL)

Cytokine and via Mesoscale in induced sputum (pg/mL)

Change in Cytokine concentrations in Nasal Epithelial Lining Fluid (NELF)

Cytokine via Mesoscale in NELF

Change in Change in cytokine concentrations in Nasal Epithelial Lining Fluid (NELF)

Cytokine and via Mesoscale in NELF

Change in Fraction of Exhaled Nitric Oxide (FENO) levels in parts per billion (PPB)

Changes in FeNO levels in ppb (6 hours post ozone - post air)

Change in FENO levels in parts per billion (PPB)

Changes in FeNO levels in ppb (24 hours post ozone - post air)

Full Information

NCT ID

NCT04109807

First Posted

September 23, 2019

Last Updated

October 3, 2023

Sponsor

University of North Carolina, Chapel Hill

Collaborators

Environmental Protection Agency (EPA), North Carolina State University

1. Study Identification

Unique Protocol Identification Number

NCT04109807

Brief Title

Effects of Low Dose Ozone on Airway Inflammatory Responses in Adults With Asthma - Sedentary Nasal Ozone (Asthma SNOZ)

Official Title

Effects of Low Dose Ozone on Airway Inflammatory Responses in Adults With Asthma Asthma SNOZ

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Suspended

Why Stopped

Enrollment for this study was stopped due to Covid and will resume once it is determined acceptable to do inhalational challenges.

Study Start Date

December 16, 2019 (Actual)

Primary Completion Date

October 2024 (Anticipated)

Study Completion Date

October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of North Carolina, Chapel Hill

Collaborators

Environmental Protection Agency (EPA), North Carolina State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

To determine if low levels of ozone (O3) encountered on a typical day in Chapel Hill will decrease spirometric values in mild asthmatics.

Detailed Description

Short-term exposure to ambient air ozone has been recognized for decades to be adversely associated with impacts on the respiratory system. Indeed the evidence is such that the Environmental Protection Agency (EPA) has determined that there is a causal relationship, and even lowered the 8-hour exposure standard to 0.07 parts per million (ppm) in 2015. Controlled human exposure studies and epidemiological studies have consistently observed ozone-associated decrements in lung function and increased respiratory symptoms. Most controlled human exposure studies have been performed with high ozone concentrations. Additionally, epidemiologic studies have focused on populations engaged in outdoor activities (increasing ozone exposure through increased minute ventilation), or in cities such as Los Angeles or Mexico City where ambient ozone levels are especially high. Evidence has recently emerged that exposure to low ozone concentrations also produces adverse health effects, especially among susceptible groups including children with asthma. The objective of this study is to examine if low level ozone exposure (compared to a clean air exposure), reflective of a typical metropolitan summer day, will cause decrements in lung function and measurable upper and lower airway inflammation in mild asthmatics (who are not on asthma controller medications) while performing typical daily activities.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma, Allergic

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

6 hour Filtered Air (FA) followed by O3 exposure

Arm Type

Experimental

Arm Description

Arm Title

6 hour O3 exposure followed by FA exposure

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Ozone

Intervention Description

ozone exposure

Intervention Type

Other

Intervention Name(s)

Intervention Description

Filtered air exposure

Primary Outcome Measure Information:

Title

Change in Percent (%) predicted forced expiratory volume at one second (FEV1)

Description

Change from baseline %predicted FEV1 post-O3 versus post-air exposure.

Time Frame

6 hours post-O3 versus post-air exposure versus pre-exposure

Secondary Outcome Measure Information:

Title

Change in Percent (%) predicted forced vital capacity (FVC)

Description

Change from baseline %predicted FVC post-O3 versus post-air exposure.

Time Frame

6 hours post-O3 versus post-air exposure versus pre-exposure

Title

Change in Percent eosinophils in induced sputum

Description

% eosinophils in induced sputum (24 hrs post ozone - post air)

Time Frame

24 hours post-O3 versus post-air exposure

Title

Change in Percent (%) neutrophils in induced sputum

Description

% neutrophils in induced sputum (24 hrs post ozone - post air)

Time Frame

24 hours post-O3 versus post-air exposure

Title

Change in Eosinophils per mg of induced sputum

Description

Eosinophils per mg of induced sputum (24 hrs post ozone - post air)

Time Frame

24 hours post-O3 versus post-air exposure

Title

Change in neutrophils per mg of induced sputum

Description

Neutrophils per mg of induced sputum (24 hrs post ozone - post air)

Time Frame

24 hours post-O3 versus post-air exposure

Title

Change in Cytokine concentrations in induced sputum picograms per milliliter (pg/mL)

Description

Cytokine and via Mesoscale in induced sputum (pg/mL)

Time Frame

24 hours post-O3 versus post-air exposure

Title

Change in Cytokine concentrations in Nasal Epithelial Lining Fluid (NELF)

Description

Cytokine via Mesoscale in NELF

Time Frame

6 hours post-O3 versus post-air exposure

Title

Change in Change in cytokine concentrations in Nasal Epithelial Lining Fluid (NELF)

Description

Cytokine and via Mesoscale in NELF

Time Frame

24 hours post-O3 versus post-air exposure

Title

Change in Fraction of Exhaled Nitric Oxide (FENO) levels in parts per billion (PPB)

Description

Changes in FeNO levels in ppb (6 hours post ozone - post air)

Time Frame

6 post-O3 post-air exposure versus pre-exposure

Title

Change in FENO levels in parts per billion (PPB)

Description

Changes in FeNO levels in ppb (24 hours post ozone - post air)

Time Frame

24 hours post-O3 versus post-air exposure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Ages 18-45, both sexes included Mild intermittent asthma, defined as daytime asthma symptoms no more than 2 times per week, night time asthma symptoms no more than 2 times per month, FEV1 >80% of predicted, and asthma exacerbation requiring oral steroids 1 time or less per year. Good general health as evidenced by medical history Vital signs will be within normal limits on admission to the study: oxygen saturation by pulse oximetry (SpO2) > 94%, systolic blood pressure between 150-90 mm Hg, diastolic blood pressure between 100-60 mm Hg, afebrile. FEV1 of at least 80% of predicted at baseline Able to provide informed consent Proof of Covid Vaccination Exclusion Criteria: Any chronic medical condition considered by the PI as a contraindication to the exposure study including significant cardiovascular disease, diabetes, chronic renal disease, chronic thyroid disease, history of chronic infections/immunodeficiency, history of tuberculosis Physician directed emergency treatment for an asthma exacerbation within the preceding 12 months Orthopedic injuries or impediments that would preclude bicycle or treadmill exercise Viral upper respiratory tract infection within 4 weeks of challenge. Any acute infection requiring antibiotics within 4 weeks of exposure or fever of unknown origin within 2 weeks of challenge. Individuals who use daily controller medication for asthma. Pre-treatment with a short acting bronchodilator prior to exercise is allowed. Nasal surgery within 6 months Mental illness or history of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements. Any recent or current use of nicotine History of intubation for asthma Pregnancy or nursing an infant as EPA strictly prohibits intentional exposure for research to this population. Covid infection in the past 90 days

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Peden, MD

Organizational Affiliation

UNC SOM

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of North Carolina CEMALB

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

IPD Sharing Time Frame

9 to 36 months following publication

IPD Sharing Access Criteria

Approval from an IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Learn more about this trial

Effects of Low Dose Ozone on Airway Inflammatory Responses in Adults With Asthma - Sedentary Nasal Ozone (Asthma SNOZ)

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